A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
OBJECTIVES:
Primary
- Evaluate the histologic result of treating patients with primary stage I non-small cell
lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).
Secondary
- Provide a qualitative assessment of the histology from the ablation and tumor margins,
comparing histologic observations with imaging-enhancement patterns by CT or PET scan
before and after PTC.
OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours.
Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of
lobectomy of the primary lung cancer or wedge resection with adequate margin for the
metastatic lesion, and mediastinal lymph node dissection.
Tissue samples from ablation and tumor margins are collected during thoracotomy and compared
with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.
After completion of study therapy, patients are followed periodically for 6 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response and partial response)
3 weeks post-Percutaneous Cryotherapy (PTC)
No
Frank A. Baciewicz, MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
CDR0000640304
NCT00890617
March 2009
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |